This page was originally created on the PIUG website by Kenneth Allison, Anne Backman and Edlyn Simmons and last edited by Elyse Turner. It has been moved "as is" except for correcting links.
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Original questions: Have others noted discrepancies among sources for term extension data? Which is authoritative or most reliable?
Origin of the Data
The Food and Drug Administration (FDA) publishes in the Federal Register the time the extension is applied for.
When the extension is granted the United States Patent and Trademark Office (USPTO) puts the information in the Official Gazette (OG).
Sources for the Data
- The USPTO lists of extensions is at http://www.uspto.gov/web/offices/pac/dapp/opla/term/. The USPTO adds expiration to its list whenever an extension is granted.
- The FDA provides full online access to the entire Orange Book (APPROVED DRUG PRODUCTS with Therapeutic Equivalence Evaluations). The 29th Edition (2009) contains a "Patent and Exclusivity Information Addendum" with lists and terms. In addition, there's a series of cumulative supplements available from the main Orange Book page.
Those documents list the generic drug names with patent numbers, dates, and exclusivity codes. They don't have the information the OG publishes about the numbers of days the patents are extended. And the FDA lists only current exclusivity data. An extended patent that expired in the past isn't listed. Patent numbers are provided by the owner of the approved drugs, not collected by anyone at the FDA. The expiration dates are intended as warnings to potential infringers. If the patent were to be extended, the patentee would have to notify the FDA if it wanted the extended date to be listed. "One of our attorneys has told me that there's no provision of the law or regulations that requires the patentee to notify the FDA about the extension. The bottom line seems to be that the Orange Book shouldn't be used as the exclusive source of information about patent expiration dates."
- Drugs Under Patent from FOI. FOI gets its information from the annual FDA listing, and doesn't publish supplements. FOI lists only current exclusivity data.
- IFI CLAIMS® Patent Services gets the data from the weekly hard copy of the USPTO OG and posts it shortly thereafter to the CLAIMS Reassignment/Reexam file. Whenever there's an extension in the OG it would be posted to the file.